Senior Manager, Regulatory Submission Management (...
Atrium Works - Boston, MA
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The Regulatory Submission Management Senior Manager is responsible for the planning, managing and tracking of the regulatory portfolio of submissions for an assigned program. This role will be responsible for developing comprehensive plans and reports that would include all major milestones and other key dates related to the filings. The plans would be used within regulatory to plan submission activities and resources. In addition, the plans will need to be integrated cross-functionally to ensure project team alignment on major milestones. This role will be responsible for identifying timeline risk mitigation and contingency planning within plan. This role will collaborate with key functions to collect the latest dates,understand the change drivers, update the plan and run and distribute reports to the various stakeholders.Key Duties & ResponsibilitiesLeads complex project plans from project initiation to closeout.Facilitates the definition of the project milestones, tasks, deliverables, key dependencies and resource requirements.Develops complex project plans, status reports, issue logs, and other project-related artifacts.Identifies facilitating strategies for risk mitigation and contingency planning within plan.Identifies and resolves complex project plan issues and takes a new perspective on existing solutions.Communicates project status, difficult or sensitive issues, schedule and accomplishments to various management and stakeholder groups, as needed, and works to build alignmentPrepares necessary reports to drive data-driven resource, budget and trade-off discussions across GRA functionRequired Education & Experience LevelBachelor’s degree in life sciences or technology areaTypically requires 6 years of project management experience in regulatory/clinical project management or project management experience in a life sciences company, or the equivalent combination of education and experienceExperience in regulatory filing project managementExpertise in project management toolsIn-depth conceptual knowledge of types of Global HA submissions and requirements and guidelinesAbility to work with firm deadlines and adapt quickly to changing requirements and prioritiesExcellent organization, written/verbal communication, and attention to detail to explain difficult information and works to build alignmentStakeholder management skillsAbility to balance multiple tasks to meet priorities and timelines$85-$95/hrThis job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirementsBy applying for this position, you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials, which may include your CV/Resume, email address or phone number, with Vertex. For more information on how Vertex handles your personal data related to your job application, please see Vertex’s Careers Privacy Notice. Agreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners(collectively, “Atrium Alerts”). Atrium Alerts may be sent by email, phone, or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time, please contact Atrium at do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at include the job title in the subject of your email.No C2C or Third-Party Vendors
Created: 2024-09-19